MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSO NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D134302

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where thrombus occurred.Clot formed on shaft of the lasso® nav eco variable catheter.Case abandoned.No patient consequence.The transeptal puncture was performed.The lasso® nav eco variable catheter was passed into the left atrium whilst preparing for a second pass it was noted by the transoesophageal echocardiography physician that there was a clot on the shaft of the lasso® nav eco variable catheter.The system did not present any error messages.The patient was anticoagulated ((b)(4)).The patient was under general anesthesia for approx.2 hours.In the physician¿s opinion cancelation of the procedure could not contribute to a death or a serious injury to the patient.Extended hospitalization was not required.Procedure was aborted due to thrombus formation and risk of embolism.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a lasso® nav eco variable catheter where thrombus occurred.Clot formed on shaft of the lasso® nav eco variable catheter.Case abandoned.No patient consequence.Device evaluation details: on (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation and the evaluation has been completed.Upon receipt, the catheter was visually inspected and it was found in normal conditions: no trails of thrombus were observed.A manufacturing record evaluation was performed for the finished device number and no internal action related to the complaint was found during the review.The customer complaint cannot be duplicated as intended.There is no evidence of thrombus residues were observed on the catheter.The device was found in normal conditions.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

• Brand Name: LASSO NAV ECO VARIABLE CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10849329
• MDR Text Key: 247887178
• Report Number: 2029046-2020-01757
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2023
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30352694L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1